Daily human interaction requires the exchange of ideas, language, symbols, data, messages, or other communications. In some situations, legal consequences arise if information is not communicated effectively. Examples of information which, if miscommunicated or not fully appreciated by the recipient can give rise to legal ramifications, are numerous. Such examples include, but are not limited to, patient information regarding the risks associated with medical procedures, and patient information regarding the use and potential side effects of medicinal drugs. Further examples include information relating to the risks associated with certain leisure or sporting activities (e.g., horseback riding, hang gliding, bungee jumping, parachuting, etc.), and information relating to the use of motor vehicles, machinery, and equipment. Moreover, another example includes any information that potentially affects the legal rights of the recipient (e.g., legal effects of taking breathalyzer tests, legal effects associated with acknowledging receipt and understanding of Miranda warnings, legal effects of accepting a plea bargain in the context of criminal litigation or a settlement offer in the context of civil litigation).
Regarding informed consent in medical procedures, the principle of informed consent is endorsed by the American College of Surgeons. The Statement ofPrinciples of the College says, in part: "Patients should understand the indications for the operation, the risks involved and the result that it is hoped to attain." Further, the College states that doctors should be willing to take whatever time is necessary to make sure the patient is fully informed and should not guarantee outcomes due to the individual differences of each patient. Research shows that the patient's unmet expectation of the outcome of surgical treatment is one of the most cited reasons for medical malpractice litigation in the United States today. Medical informed consent law requires disclosure of the risk of and alternative to suggested medical procedures to enable patients to make knowledgeable decisions about the course of their medical care. United States courts almost unanimously treat lack of informed consent as a matter of negligence on the part of the physician to disclose necessary information to patients.
The U.S. medical malpractice litigation crisis is well documented. Medical malpractice tort costs have increased 48.5% between 1990 and 1995, almost triple the 16.6% increase in overall tort costs during the same period (Tillinghast-Towers Perrin 1995, "Tort Cost Trends; An International Perspective"). According to the American Medical Association, nearly 40% of all physicians are sued at least once during their careers. The American Medical News published a report stating that medical malpractice awards have increased from an average of $1.214 million in years 1985-1989 to $1.906 million in years 1990-1995.
A close look at how informed consent is currently being given is revealing. It is not uncommon for a patient to be asked to consent to a medical or surgical procedure for diagnostic or curative purposes on the initial visit to a physician. During a 15 to 20 minute office visit, the patient must decide whether to trust the physician's expertise and follow the proposed treatment recommendations. It is up to the physician to educate the patient regarding the necessity of the procedure and its risk and benefits. However, the information presented is variable and often inconsistent. While educational material is available in a variety of media including paper, video, audio and digital files, it is not always up to date and easily accessible. Patients give their consent solely on what the physician tells them or on their understanding of the educational material they receive from the physician during the office visit.
Typically, written consent forms are used by those conveying information to a recipient in an attempt to insulate the information provider from claims that the information was not provided or was not provided effectively. Such written consent forms either contain the information itself or are executed by the recipient after oral communication of the information to the recipient by the information provider. These written consent forms generally state that execution of the consent form evidences receipt and understanding by the recipient of the information conveyed, as well as consent to the risks as described in the consent form or the associated information conveyed to the recipient.
However, consent forms alone are not necessarily the best solution to the problem of informed consent. A signed consent form does not necessarily provide insight into the state of mind, comprehension, or capacity of the recipient. For example, there may be no indication of fraud, fatigue, misunderstanding, lapse of attention, coercion or other relevant factors that prevent the recipient from fully understanding the nature of the information conveyed, arguably rendering any such consent ineffective. If the consent is ineffective, the recipient could suffer physical, legal, pecuniary or other injury which was not contemplated by the recipient. The recipient might attempt to hold the information provider liable for such injury, for, among other grounds, failure to effectively communicate the necessary information to the recipient. Therefore, uncertainty over whether the information was effectively communicated to and understood by the recipient could expose the information provider to liability despite the existence of a signed consent form.
Attempts have been made to provide information to a recipient and to test the understanding of the information using audiovisual equipment as opposed to, or in addition to, the written consent form. The following United States Patent Nos. disclose audiovisual instruction devices that may be used for informed consent: U.S. Pat. Nos. 3,273,260; 3,939,579; 3,504,445; 4,482,328; 4,552,535; 3,481,052; 3,968,576; and, 3,946,503.
U.S. Pat. No. 3,946,503 to Buchan et al. discloses a device that presents a pre-formatted audiovisual presentation to educate medical patients or other individuals on a subject. The visual portion of the presentation comprises a filmstrip and is displayed on an illuminated screen. The audio portion includes a synchronized audio tape. The Buchan device also discloses obtaining a patient's or individual's responses or answers to test questions in a condensed electrically coded form on a tape cassette. More particularly, by recording a series of tones on the cassette tape, the Buchan apparatus is able to link the questions with the answers. To retrieve the individual's responses, the audiotape is replayed whereupon the participant's responses are displayed using illuminated lights. The Buchan apparatus also provides for bypassing a series of subordinate or branching sequences of questions in response to the selection of a predetermined answer to a primary question. The Buchan apparatus is adapted to record its data in condensed form and transmit that data by a data phone set to a remotely located computer which is programmed to process the data.
The Buchan device, however, has several limitations. The Buchan device provides no visual or other authentication, like an electronic signature or retinal scan, for use in conclusively establishing that a particular individual actually engaged in the learning session. Nor does the Buchan device provide an indication of the questioning environment, such as the degree of privacy or opportunities for fraud and coercion. Also, the Buchan device fails to record the response or reaction of the recipient to the information presented along with the simultaneous presentation of the information. Thus, while generally adequate for displaying information to a person, the typical audiovisual device may not provide sufficient evidence of receipt of the information and/or the demeanor, comprehension, or overall mental and physical state of the recipient in order to adequately prove that a particular individual received certain information and was capable of understanding and fully appreciating the information conveyed.
Over the past decade, pressure has increased for healthcare providers and hospitals to contain healthcare costs while maintaining high quality care. This pressure has affected the patient-physician relationship, as it necessitates physicians to accomplish more with each patient in less time. Simply put, cost containment requires more efficient delivery of care, and too often at the expense of the patient-physician relationship. The growing regulations and administrative burdens placed on healthcare providers has additionally accelerated the need for technology-based solutions. Consequently, there is a need to enhance the quality of the patient-physician experience prior to invasive medical procedures using a method and apparatus for presenting information to a recipient while establishing receipt and comprehension of the information. There is also a need for the simultaneous provision of a correlated record of the information along with the responses. The correlated record should be capable of being archived, stored, retrieved and observed for later use. It would be particularly advantageous if the correlated record could be permanently, confidentially, and compactly stored.